How to Evaluate Principal Investigator Experience in Feasibility Questionnaires

Why PI Experience Is Critical to Trial Success

The success of any clinical trial relies significantly on the capabilities of the Principal Investigator (PI). A well-qualified PI ensures proper protocol execution, adherence to Good Clinical Practice (GCP), efficient patient recruitment, and timely data entry. As such, assessing PI experience during the feasibility process is a regulatory and operational necessity. Regulatory authorities like the FDA, EMA, and PMDA emphasize robust PI qualification checks during inspections and sponsor audits.

Feasibility questionnaires are a primary tool for gathering critical information on PI qualifications, experience, and history. If designed correctly, they provide insights into whether a site has the leadership and clinical expertise to conduct the study. Poorly evaluated PIs can lead to protocol deviations, delayed timelines, and even inspection findings.

This article explores the key elements to assess PI experience through feasibility questionnaires, including document review, scoring methods, red flags, and regulatory alignment.

Core Domains to Evaluate PI Experience

A comprehensive feasibility questionnaire should assess multiple dimensions of a PI’s capability:

• Clinical Trial Experience: Number and type of trials conducted (Phase I–IV)
• Therapeutic Area Specialization: Alignment with the protocol indication
• Regulatory History: Inspections, 483 observations, or GCP violations
• Training Credentials: GCP certifications and investigator training logs
• Site Oversight Capacity: Number of trials currently managed

Example questions in a feasibility survey might include:

Document Verification: Going Beyond the Survey

Questionnaire responses alone are not sufficient. Sponsors must request and verify supporting documentation:

• Signed and dated PI CV (within past 2 years)
• GCP certification (ICH E6-compliant, dated within past 2 years)
• Training logs for protocol-specific modules
• Documentation of PI delegation logs from past trials
• Inspection reports or audit summaries (if available)

These documents must be reviewed, archived in the eTMF, and aligned with feasibility questionnaire answers. Discrepancies—such as overstated experience or outdated GCP certificates—should be flagged for clarification before site selection.

For cross-validation, sponsors can refer to clinical trial registries such as ANZCTR to review PIs listed in past studies and compare enrollment timelines and completion status.

Scoring Systems for PI Evaluation

Many sponsors and CROs use scoring systems to quantify PI suitability during the feasibility phase. These scores are based on multiple weighted criteria:

PIs scoring below a predefined threshold (e.g., 70/100) may require additional review or exclusion from site consideration. The scoring model can be automated via CTMS-integrated feasibility platforms.

Red Flags in PI Feasibility Assessments

Watch for these common issues in questionnaire responses or supporting documents:

• PI CV missing or outdated
• More than 5 concurrent studies under PI oversight
• No evidence of protocol-specific training
• Prior inspection with unresolved CAPA
• Enrollment performance not aligned with feasibility estimates

Such red flags should trigger a follow-up interview or teleconference with the site to clarify discrepancies. Regulatory inspectors frequently review these inconsistencies when auditing site selection processes.

Case Study: Protocol Deviations Linked to Inadequate PI Oversight

In a Phase II oncology study, one investigator site experienced 14 protocol deviations within 3 months. Upon review, the feasibility questionnaire listed the PI as experienced, but later it was found that the PI had not attended protocol training and was concurrently managing 7 studies. FDA inspection identified this oversight as a major finding. The sponsor was required to implement new SOPs for PI qualification and conduct a full re-training across all sites.

Regulatory Expectations for PI Evaluation

According to ICH E6(R2), sponsors are required to:

• Evaluate PI qualifications and capability to oversee the trial (Section 5.6)
• Maintain up-to-date records of PI experience, CV, and training (Section 8.2)
• Ensure proper supervision of site staff and trial conduct (Section 4.2)

The FDA’s Bioresearch Monitoring Program also audits how PI qualifications were verified during feasibility and whether their involvement was adequately documented in the TMF.

Best Practices for PI Evaluation Through Questionnaires

• Customize PI sections in feasibility surveys based on protocol complexity
• Use weighted scoring systems for objective evaluation
• Digitally link PI questionnaire responses to their training and inspection history
• Require e-signatures on PI forms to ensure accountability
• Update PI evaluations at study milestones (e.g., mid-recruitment checkpoint)

Conclusion

Evaluating the Principal Investigator’s experience and qualifications is a cornerstone of effective clinical trial feasibility planning. Through well-designed feasibility questionnaires, sponsors can screen for both technical and regulatory competence, minimize risks of protocol violations, and improve trial outcomes. By implementing structured, compliant, and validated PI evaluation frameworks, sponsors not only meet regulatory expectations but also strengthen the foundation for high-quality trial execution.